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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02993744
Other study ID # 2130/2015
Secondary ID
Status Completed
Phase N/A
First received December 7, 2016
Last updated May 25, 2017
Start date September 2016
Est. completion date May 2017

Study information

Verified date May 2017
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It is the aim of this study to detect the effect of Betamethasone on the maternal inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under threat of preterm delivery, for example because of a cervical infection.


Description:

BACKGROUND

Cortisone influences the maternal number of leukocytes and CRP of a pregnant woman. Because of that, it is difficult to know if the medical treatment of an infection was successful and accordingly if the diagnosis was justified.

METHODS

In this study, the blood results of 75 pregnant women under threat of preterm delivery (week of gestation 23+0 to 34+6), treated with Betamethasone will be analysed. 65 pregnant women without complications serve as control group.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- week of gestation 23+0 until 34+6

Exclusion Criteria:

- infectious diseases f.e. hepatitis B or C, HIV

- diseases of the thyroid gland

75 Patients facing preterm labour 65 Patients acting as a control group, without preterm labor

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria General Hospital Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Other Body Mass Index (BMI) Body Mass Index (BMI) in kg/m^2 is calculated to test for influence on inflammatory parameters in both groups (case and control) single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
Other Weight Weight in kilogram (kg) is taken from the medical record to calculate the BMI in both groups (case and control) single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
Other Height Size in meters (m) is taken from the medical record to calculate the BMI in both groups (case and control) single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
Other CRP Control Group CRP values in mg/dL of patients belonging to the control group single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
Other Leucocytes Control Group Leucocyte values in G/L of patients belonging to the control group single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
Other Patients with Allergies information about the patients allergie status (allergies yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control) single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
Other Patients with Diabetes information about the patients diabetes status (diabetes yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control) single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
Other Smoking Habits information about the patients smoking status (smoking yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control) single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
Primary CRP The CRP values in mg/dL before and 48h after the first Betamethasone application 48h
Secondary Leucocytes The Leucocyte values in G/L before and 48h after the first Betamethasone application 48h
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